# FDA 483 - Perceptive Informatics LLC - February 23, 2012

Source: https://www.globalkeysolutions.net/records/483/perceptive-informatics-llc/64e6b8f7-c624-49ed-a52c-ceef350926db

> FDA 483 for Perceptive Informatics LLC on February 23, 2012. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Perceptive Informatics LLC
- Inspection Date: 2012-02-23
- Product Type: other
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Perceptive Informatics, Inc., a Contract Research Organization in Billerica, MA, revealed a significant failure to ensure studies were conducted in accordance with the protocol and investigational plan. The inspection found deficiencies in training, independent review processes, and documentation supporting study tasks. These issues indicate a lack of adherence to established study procedures.

## Related Documents

- [483 - 2013-10-04](https://www.globalkeysolutions.net/records/483/perceptive-informatics-llc/295702c3-8af6-4eb1-9e72-e510b48cfef9)

## Related Officers

- [Darin S. Wiegers](https://www.globalkeysolutions.net/people/darin-s-wiegers/5bf03f8b-1571-4845-916d-3211d72d97a2)

Company: https://www.globalkeysolutions.net/companies/perceptive-informatics-llc/ef10b6aa-4cfc-469b-9017-389917aa871f

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7